(60 days)
No
The device description and performance studies focus on a manual, gradient-based method for determining MIC, with no mention of automated analysis, image processing, or AI/ML algorithms.
No
The device is described as a diagnostic tool used to determine the antimicrobial susceptibility of bacteria by calculating the Minimum Inhibitory Concentration (MIC) of various antimicrobial agents. It does not directly treat or prevent a disease, which is the function of a therapeutic device.
Yes
The device is used to determine the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms, which is a diagnostic technique for assessing antimicrobial susceptibility.
No
The device description clearly states it is a "thin, inert and non-porous plastic strip" with an antibiotic gradient, which is a physical hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is a "manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria." This involves testing biological samples (bacteria) in vitro (outside the body) to provide information about their susceptibility to antimicrobial agents.
- Device Description: The description details a physical strip with an antibiotic gradient used in conjunction with agar media and bacterial growth, all of which are components of in vitro testing.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard in vitro diagnostic technique for determining antimicrobial susceptibility. The metrics reported (Essential Agreement and Category Agreement) are standard measures used to evaluate the performance of in vitro diagnostic devices in this field.
- Predicate Device: The mention of a predicate device (ETEST® Telavancin) with a K number (K180936) indicates that this device is being submitted for regulatory clearance as a medical device, specifically an IVD, by demonstrating substantial equivalence to a previously cleared IVD.
All these elements strongly indicate that the ETEST® Delafloxacin device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.
Delafloxacin has been shown to be active against the aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.
ETEST® DFX can be used to determine the MIC of Delafloxacin against the following microorganisms:
Active both in vitro and in clinical infections:
Gram-positive bacteria:
-
· Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible strains)
-
Staphylococcus haemolyticus
-
Staphylococcus lugdunensis
-
Enterococcus faecalis
Gram-negative bacteria: -
Pseudomonas aeruginosa
Product codes
JWY
Device Description
ETEST® is a thin, inert and non-porous plastic strip carrying on one side the MIC reading scale in ug/mL, and on the other side a predefined antibiotic gradient.
When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
ETEST® Delafloxacin contains a range of delafloxacin from 0.002 to 32 u2/mL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Delafloxacin (DFX) (0.002-32 µg/mL) by comparing with the CLSI broth microdilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ETEST® Delafloxacin (DFX) (0.002-32 ug/mL) demonstrated substantially equivalent performance when compared with the CLSI M07-A11 January 2018 broth microdilution reference method, following rules as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued on August 28, 2009 and following specifications as defined in CLSI M100-S29 January 2019.
This Premarket Notification (510/k)) presents data in support of ETEST® Delafloxacin (DFX) (0.002-32 ug/mL) for: Staphylococcus aureus (including methicillin-resistant and methicillinsusceptible strains), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Enterococcus faecalis and Pseudomonas aeruginosa.
The performance characteristics for ETEST® Delafloxacin are as follows:
For Staphylococcus aureus (methicillin resistant and methicillin-susceptible isolates): Essential Agreement (EA) = 96.5%, Category Agreement (CA) = 93.0%.
For Staphylococcus haemolyticus: EA = 100.0%, CA = 93.5%.
For Staphylococcus lugdunensis: EA = 100.0%, CA = Not applicable (Delafloxacin breakpoints for S. lugdunensis were not established by the FDA).
For Enterococcus faecalis: EA = 100.0%, CA = 96.1%.
For Pseudomonas aeruginosa: EA = 98.5%, CA = 95.5%.
Reproducibility and Quality Control demonstrated acceptable results. Reproducibility for both Best-case and Worst-case scenarios was 100%. Quality Control results were within range > 95% of the times tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) = % of MIC values within ± 1 dilution of the reference method.
Category Agreement (CA)
Performance Characteristics:
Staphylococcus aureus (methicillin resistant and methicillin-susceptible isolates): EA = 96.5, CA = 93.0
Staphylococcus haemolyticus: EA = 100.0, CA = 93.5
Staphylococcus lugdunensis: EA = 100.0, CA = Not applicable
Enterococcus faecalis: EA = 100.0, CA = 96.1
Pseudomonas aeruginosa: EA = 98.5, CA = 95.5
Reproducibility:
Best-case: 100%
Worst-case: 100%
Quality Control:
Results within range > 95% of the times tested.
Predicate Device(s)
ETEST® Telavancin (TLA) (0.002 – 32 µg/mL) (K180936)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
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November 26, 2019
BioMerieux SA Sophie Quiblier Regulatory Affairs Specialist 376. Chemin de L'Orme Marcy L'Etoile, 69280 Fr
Re: K192738
Trade/Device Name: ETEST Delafloxacin (DFX) (0.002-32 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: September 26, 2019 Received: September 27, 2019
Dear Sophie Quiblier:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar, Ph.D. (ABMM) Chief. General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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ETEST® Delafloxacin (DFX) (0.002-32 µg/mL)
A. 510(k) Submission Information:
| Submitter's Name: | bioMerieux SA |
|---|---|
| Address: | 376 Chemin de l'Orme |
| 69280 Marcy-l'Etoile, FRANCE | |
| Contact Person: | Sophie Quiblier |
| Regulatory Affairs Specialist | |
| Phone Number: | +33 (0)4 78 87 75 71 |
| Date of Preparation: | September 26th, 2019 |
B. Device Name:
| Formal/Trade Name: | ETEST® Delafloxacin (DFX) |
|---|---|
| (0.002 – 32 µg/mL) | |
| Classification Name: | 21 CFR 866.1640 |
| Manual Antimicrobial Susceptibility Test Systems | |
| Product Code: JWY | |
| Common Name(s): | ETEST® Delafloxacin; ETEST® DFX |
| C. Predicate Device: | ETEST® Telavancin (TLA) |
| (0.002 – 32 µg/mL) (K180936) |
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D. Device Description:
ETEST® is a thin, inert and non-porous plastic strip carrying on one side the MIC reading scale in ug/mL, and on the other side a predefined antibiotic gradient.
When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
ETEST® Delafloxacin contains a range of delafloxacin from 0.002 to 32 u2/mL.
E. Intended Use:
ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.
Delafloxacin has been shown to be active against the aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.
ETEST® DFX can be used to determine the MIC of Delafloxacin against the following microorganisms:
Active both in vitro and in clinical infections:
Gram-positive bacteria:
- · Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible strains)
- Staphylococcus haemolyticus
- Staphylococcus lugdunensis
- Enterococcus faecalis
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Gram-negative bacteria:
- Pseudomonas aeruginosa
F. Summary of the technological characterictics of the new device in comparison to those of the predicate device.
The similarities and differences of ETEST® Delafloxacin (DFX) when compared to the predicate device, ETEST® Telavancin (TLA)(K180936) are described in the table below:
| Test Device | Predicate Device | |
|---|---|---|
| Similarities | ||
| ETEST® Delafloxacin (DFX) | ||
| (0.002-32 µg/mL) | ETEST® Telavancin (TLA) | |
| (0.002-32 µg/mL) | ||
| Intended Use | ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in µg/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight | ETEST® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is |
| incubation. | ||
| Delafloxacin has been shown to | ||
| be active against the aerobic | ||
| microorganisms listed below | ||
| according to the FDA label for | ||
| this antimicrobial agent. | used to determine the Minimum | |
| Inhibitory Concentration | ||
| (MIC), in μg/mL, of different | ||
| antimicrobial agents against | ||
| microorganisms as tested on | ||
| agar media using overnight | ||
| incubation. | ||
| ETEST® DFX can be used to | ||
| determine the MIC of | ||
| Delafloxacin against the | ||
| following microorganisms: | Telavancin has been shown to | |
| be active against the Gram- | ||
| positive aerobic | ||
| microorganisms listed below | ||
| according to the FDA label for | ||
| this antimicrobial agent. | ||
| Active both in vitro and in | ||
| clinical infections: | ||
| Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible strains) Staphylococcus haemolyticus Staphylococcus lugdunensis Enterococcus faecalis Pseudomonas aeruginosa | Active both in vitro and in | |
| clinical infections: | ||
| Staphylococcus aureus (including methicillin resistant isolates) Enterococcus faecalis: (vancomycin-susceptible only) |
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| Clinical &
Challenge
Performance
Data | Acute Bacterial Skin and Skin
Structure Infections (ABSSSI)
indication | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | Staphylococcus aureus
(methicillin resistant and
methicillin-susceptible
isolates):
EA = 96.5%
CA = 93.0% | Staphylococcus aureus:
EA = 98.4%
CA = 97.9% |
| | Staphylococcus haemolyticus:
EA = 100%
CA = 93.5% |
• Enterococcus faecalis:
(vancomycin-susceptible
only)
EA = 91.6%
CA = 97.6% |
| | Staphylococcus lugdunensis
EA = 100%
CA : Not applicable | |
| | Enterococcus faecalis:
EA = 100%
CA = 96.1% | |
| | Pseudomonas aeruginosa: | |
| | EA = 98.5% | |
| | CA = 95.5% | |
| | Community Acquired Bacterial
Pneumonia (CABP) indication | |
| | Staphylococcus aureus
(methicillin-susceptible
isolates): | |
| | EA = 97.3% | |
| | CA = 91.8% | |
| | | |
| | Pseudomonas aeruginosa: | |
| | EA = 98.5% | |
| | CA = 95.5% | |
| | | |
| Reproducibility | Best-case: 100% | Best-case: 100% |
| | Worst-case: 100% | Worst-case: 100% |
| Quality Control | Results within range > 95% of
the times tested. | Results within range > 95% of
the times tested. |
| Meets Guidance
Document
Performance
Requirements | Yes | Yes |
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| Differences | ||
|---|---|---|
| Antimicrobial | ||
| Agent | Delafloxacin | Telavancin |
| Claimed species | Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible strains) Staphylococcus haemolyticus Staphylococcus lugdunensis Enterococcus faecalis Pseudomonas aeruginosa | Staphylococcus aureus (including methicillin resistant isolates) Enterococcus faecalis : (vancomycin-susceptible only) |
G. Performance Overview
ETEST® Delafloxacin (DFX) (0.002-32 ug/mL) demonstrated substantially equivalent performance when compared with the CLSI M07-A11 January 2018 broth microdilution reference method, following rules as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued on August 28, 2009 and following specifications as defined in CLSI M100-S29 January 2019.
This Premarket Notification (510/k)) presents data in support of ETEST® Delafloxacin (DFX) (0.002-32 ug/mL) for: Staphylococcus aureus (including methicillin-resistant and methicillinsusceptible strains), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Enterococcus faecalis and Pseudomonas aeruginosa.
External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Delafloxacin (DFX) (0.002-32 µg/mL) by comparing with the CLSI broth microdilution reference method.
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ETEST® Delafloxacin (DFX) (0.002-32 ug/mL) demonstrated acceptable performance as presented in Table 1 below:
| | % Essential Agreement
(EA)a) | % Category Agreement
(CA) |
|-------------------------------------------------------------------------------------------------|---------------------------------|------------------------------|
| Staphylococcus aureus (methicillin
resistant and methicillin-susceptible
isolates) b), c) | 96.5 | 93.0 |
| Staphylococcus haemolyticus b) | 100.0 | 93.5 |
| Staphylococcus lugdunensis b) | 100.0 | Not applicable d) |
| Enterococcus faecalis b), c) | 100.0 | 96.1 |
| Pseudomonas aeruginosa b) | 98.5 | 95.5 |
Table 1: Performance Characteristics for ETEST® Delafloxacin
Reproducibility and Quality Control demonstrated acceptable results.
Notes:
a) EA = % of MIC values within ± 1 dilution of the reference method.
b) The optional inoculator and ETEST® strip applicator can be used for plate inoculation and applying ETEST® strips onto agar media. In the ETEST® Delafloxacin clinical studies, swabs and the Inoculator RETRO C80™ were used for plate inoculation/streaking and forceps and the Vacuum Pen NEMA C88™ were used for ETEST® strip application.
c) ETEST® Delafloxacin MIC values tended to be in exact agreement or one doubling dilution higher when testing Staphylococcus aureus and Enterococcus faecalis compared to the reference broth microdilution method.
d) Category Agreement is not calculated because Delafloxacin breakpoints for S. lugdunensis were not established by the FDA.
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Conclusion:
The performance data presented in this submission support a substantial equivalence decision. ETEST® Delafloxacin (DFX) (0.002-32 µg/mL) is substantially equivalent to ETEST® Telavancin (TLA) (0.002-32 µg/mL) (K180936).